Joint Disease Clinical Trial
Official title:
Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty: A Prospective, Multicenter, Randomized Controlled Study
Verified date | April 2019 |
Source | Suzhou MicroPort OrthoRecon Co. LTD |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Osteo introducer system is the instruments used in minimal invasive THA. This study will compare the minimal invasive THA using the osteo introducer system and THA using common instruments, to show the non-inferiority of osteo introducer system in safety and efficacy of THA surgery.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 3, 2019 |
Est. primary completion date | September 13, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - With indications of total hip arthroplasty (e.g. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis; rheumatoid arthritis; correction of functional deformity, etc.) - BMI<30 - Subject is a candidate for primary total hip arthroplasty - No obvious congenital abnormality in hip joint - Subject has no mental illness, is willing to join the study voluntarily and sign the approved informed consent document; is willing and able to complete required study visits or assessments Exclusion Criteria: - Subjects with inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable - Overt infection - Distant foci of infections - Allergy to metals - Rapid disease progression as manifested by joint destruction or bone absorption apparent on X-ray - Skeletally immature - Neuropathic joints - Hepatitis or HIV infection - Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing - Pregnant or lactating women - Subjects enrolled in another drug or device clinical investigation within 3 month - Investigator has judged the subject is not suitable for the study |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Sixth People's Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Suzhou MicroPort OrthoRecon Co. LTD |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation the restoration of hip function at 3 month | Assessment the changes of Harris Hip Score at postoperative 3 month from preoperative | 3 month | |
Secondary | Evaluation of X-ray | Assessment of position, confirm whether there is loosening, dislocation or fracture etc. | 1day, 6 week, 6 month | |
Secondary | Evaluation the restoration of hip function at each time frame | Assessment the Harris Hip Score at each time frame | 6 week, 3 month, 6 month | |
Secondary | Barthel Index | Assessment the daily living activity | 1day, 3day, 2 week, 6 week, 3 month, 6 month | |
Secondary | Berg Balance Scale | Assessment the balance ability | 1day, 3day, 2 week, 6 week, 3 month, 6 month | |
Secondary | Visual Analogue Scale | Assessment the degree of pain | 1day, 3day, 2 week | |
Secondary | The use of analgesics | Investigate the name and dosage of analgesics to indirectly assess the degree of pain | 1day, 3day, 2 week, 6 week, 3 month, 6 month | |
Secondary | Adverse events | Investigate all the adverse events happened during the study period | up to 6 month | |
Secondary | Laboratory Examinations | Collect the following laboratory results which reflect the traumatic stress:Glu, CRP, Alb, CK, TBA, UA, Ca, Mg, WBC, GRA | 3 day, 6 week | |
Secondary | Dislocation rate | Compare the dislocation rate | 1day, 3day, 2 week, 6 week, 3 month, 6 month |
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